I was disappointed to hear the news that Kathleen Sebelius blocked the FDA’s recommendation to make Plan B available to all girls, over-the-counter (OTC). Plan B is an oral tablet containing hormones (similar to what is in a birth control pill) that when taken within 1 to 3 days of unprotected sex, can prevent an unwanted pregnancy. It is used as a back-up birth control. Primarily, Plan B works to delay ovulation thus making it less likely that a girl could be pregnant. Effectiveness increases the earlier a girl takes the pill after unprotected sex, so we want sexually-active teens to have it on-hand, just in case.
When it comes to Plan B, timing is everything.
Girls 17 and up can get Plan B for about $50 without a prescription. They can walk into any drug store, head back to the pharmacy counter, show an ID and purchase the pill to prevent a pregnancy. Those 16 years-old and under cannot; they must see a health provider to get Plan B. Trouble is, not every girl can see the physician when they want. Many girls at risk for an unwanted pregnancy may not have access to a clinician immediately or within a day or so. Further, girls may be too embarrassed or concerned about judgment to talk with their parent. And that’s where I start to worry; an unintended pregnancy can have significant physical and emotional health consequences.
Let me be very clear: I’m all for girls seeing their pediatrician for health advice. Particularly when it comes to getting girls access to information about protecting their bodies from unwanted pregnancies, sexually transmitted diseases, and evolving sexual experiences that put them at risk. I want them in the office whenever possible to help educate, support, and guide them in making good choices. I want to help protect them.
But drawing a line between age 16 and 17 makes little sense to me, especially when timing and access to medication factors in. And when there is safety data for an at-risk population (teens).
Today, the President endorsed Ms. Sebelius’ overturning the FDA recommendation to make Plan B available over-the-counter. President Obama said:
I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,
And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.
Isn’t Drano available for purchase alongside bubble gum and batteries, too?
The rationale for blocking the FDA, as I understand it, was based on concerns about a paucity of safety data on Plan B use in young girls, or 11 year-olds. Secretary Sebelius stated, “It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest of reproductive age.” This concern informed her position on the restriction of OTC sales to girls 16 and under.
This is a politically infused issue. And I’m not interested in the politics here. Only access to equal health care for all girls.
FDA Commissioner, Dr Margaret Hamburg responded to the news of the overturn with a statement:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER [Center for Drug Evaluation and Research] , and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
What do you think? Do you feel President Obama and Ms Sebelius did the right thing? Do you think this was a political move rather than a decision based in scientific fact? Do you feel girls are more at risk with Plan B over or under the counter? Read Dr Yolanda Evans’ (an adolescent medicine specialist) take on Plan B, too.
I would rather see parents step up and make sure that their daughter are practicing abstinence. The trouble is not that “not every girl has acess to a physician” the trouble is that too many absent fathers are punting on raising their kids well.
I am very disappointed in President Obama and Sibelius right now. Actually I’m rather angry about the whole thing. Countries that have the lowest teen pregnancy rates are the countries that make birth control easily accessible. Study after study has shown that making birth control easily available is our best tool for combating teenage pregnancy. When are we finally going to put the safety of teens over our fears of them having sex and give them access to the tools and the education that they need to protect themselves? Abstinence just doesn’t work.
Wendy Sue Swanson, MD says
I think abstinence does work, but only part of the time. And in any discussion about sexual activity, it’s our responsibility to talk about protection and the option of abstinence. But alone, counseling on abstinence alone leaves children at risk.
Andrew: “Raising their kids well” = never any need for emergency contraception? Is that serious? I was raised well, I was sent to college, and I have been married eight years and I have two very much planned for and desired children. You’d think Durex would design a condom that wouldn’t fail for people who were raised well; sadly, the technology is lacking as my experience proves. Thank goodness there is a backup method available from my local Target; I picked up some baby food for my youngest while I was picking up the pill.
I think politically motivated decisions on scientific and medical matters suck.
I agree with this decision, and feel it was made with much wisdom. I am coming from a pro-life standpoint, but in this case I will put those feelings aside, since neither Kathleen Sebelius or President Obama are pro-life individuals; therefore, their decision in this particular case is outside of the pro-life vs. pro-choice realm.
You are in support Plan B and the Gardasil vaccine that will help prevent cervical cancer and the spread of STD’s, but instead of trying to treat or “prevent” these issues, we should address the initial problem. Young people should not be sexually active. By promoting Gardisil and Plan B we are simply encouraging them to go out and have sex with whomever they want, whenever they want, without consequences. Most young people, while they may be physically ready, are not emotionally or psychologically ready to be sexually active, nor are they ready to be making decisions about Plan B without the support or counsel of trusted adults, such as their parents or doctors. Maybe this is the direction society is headed, but that doesn’t mean that it’s the right direction and that the youth of today are not suffering from these decisions and consequences or lack thereof.
In my opinion, the possibility of an unwanted pregnancy or an STD can be a good deterrent for someone to not have sex. If a girl makes the decision to have sex and then feels she needs Plan B, then she should also be mature enough to go to her parents or physician in a timely manner. If that’s not the case, then clearly she shouldn’t be choosing to be sexually active. Or maybe she didn’t choose to be sexually active, but was forced to be, and is she choosing to take Plan B or is that being forced upon her as well? This is another reason to keep it behind the counter, and require a prescription from a doctor. Perhaps the girl’s doctor might have a conversation with the girl where she learns that she doesn’t want to take Plan B, or that it wasn’t her choice to be sexually active.
Federal laws prevent me from buying Sudafed for my allergies from a drug store, without going to the pharmacy and showing my I.D., to help prevent others from making irresponsible choices, and making methamphetamine from the pseudoephedrine. Plan B should also be behind the counter to help prevent others from making irresponsible choices such as being sexually active when they are not fully ready or maybe forcing someone to take Plan B, when that individual doesn’t want to.
Dave Hoffman says
“By promoting Gardisil and Plan B we are simply encouraging them to go out and have sex with whomever they want, whenever they want, without consequences.”
No, we are not. Do air bags and seat belts in cars encourage teenagers to drive recklessly?
Nobody is saying that we should stop encouraging abstinence, or that parents shouldn’t be involved with their children’s health. The fact remains that sometimes kids make regrettable decisions, even when they know better. Unprotected sex happens, and fear of STDs and pregnancy doesn’t stop it … ESPECIALLY for teenage girls. This isn’t the 1950’s when most pregnant girls were whisked away to secretly have their babies and put them up for adoption. Now they’re most likely to stay in school for the pregnancy, keep the babies, and the 35 year old grandmas are expected to raise them. Yes, I am generalizing, but I see this scenario all of the time in my practice. Why not offer one more tool to help girls safely avoid lifelong consequences of a lapse in judgment?
Isn’t it interesting that in most states to have your driver’s license you have to be 17?
I do think that Gardisil and Plan B, along with contraception in general encourages teens to have sex recklessly. By no means do I think the 1950’s were perfect, but I think teens were in a better position then, than they are now. There were fewer teens having sex then, than there are now, and they are having sex at a much younger age then they were in the 50’s (generally speaking of course).
In my opinion, adoption, a grandparent raising a child, or the teenager(s) raising a child are all much better options than abortion or Plan B. There’s another life that you’re leaving out of the equation otherwise- what about that baby that was or would’ve been conceived? Look at the life of Steve Jobs, what if his biological mother took Plan B or didn’t give him up for adoption? His life was a gift, and the world is a better place because of him.
I’m tired of seeing the tired old “make your daughters practice abstinence and put dads back in the picture and teen pregnancy will go away!” canard being repeated.
Girls age 12-18 are the age group most likely to be raped. Many early sexual encounters are not voluntary. What good is “abstinence education” there? The majority of teen pregnancies, furthermore, are the result of statutory rapes – with men more than ten years older than the teen girl, not two teenagers who lost their heads and went too far.
Try learning about the reality of life for teenage girls in this country before you sit around judging them for being oversexed bimbos who just need to learn to cross their legs and listen to Daddy.
My husband and I disagree on this. He is firmly in the “make it available” camp. While I am prochoice, and want Plan B to be widely available (and much cheaper) for WOMEN, it seems to me that girls our daughter’s age (11) really need a doctor to determine the need, evaluate the risks and explain the dose. (THIS IS NOT the same a requirement for parental consent.) What if the child has undiagnosed health problems? What if there is abuse involved? Consulting with a doctor for a prescription helps protect the child’s health and could be a vital adult link if the suspected pregnancy is from coercion or rape. That said, I realize that time is of the essence, and some children may be unable to procure a prescription or raise the $50 before it is too late to be effective.
I see no good reason for Plan B to be so readily available to children. Aside from timing, how is this any different from needing a prescription or at the very least pharmacy counseling when buying hormone birth control. I am grateful Kathleen Sebelius stood up for what seems to me common sense.
Emily Gibson says
As a college health physician who makes this medication available to my population for half the price of the over the counter version, I’m not finding the “safety” argument compelling but how realistic is it that someone under 17 will have the $50-55 for the medication over the counter? Not very. Even my college age patients balk at paying that amount.
I think we are missing a huge educational opportunity by putting it over the counter but there is no question in my mind that having emergency contraception available at a reasonable cost for the last 20 years in our clinic has impacted the rate of unwanted pregnancies along with increasing reliable use of routine contraceptives, condoms and *yes* abstinence.
Thank you for being such a breath of fresh air. It’s great to see a physician speaking out on such a controversial topic. I think it would have been much more respectable if Mr. Obama made his comment/decision as the president of our country rather than as the father of two. What you do/tell your children is your prerogative but when you look at our society as a whole this decision was not made with the greater good in mind.
You’ve lost a follower and after some of your recent posts, I am glad you are not my child’s Dr. You wouldn’t like me as a parent either, as I believe in my right to have a say in my child’s medical care.
You arent going to elaborate for your decision to not follow? I would love to hear your reasoning.
I don’t really know anything about the politics behind the decision but as a parent it makes sense to me to not have anything that is strong and alters hormones be OTC to children with absolutely no guidance at all. But then I don’t think children should be able to buy ANY medication without some sort of guidance. In a perfect world, I would like to think all young girls have an older friend/sibling/babysitter/etc. who would go buy the pill for them if they needed it and talk to them about it. Well, in a perfect world kids would have an open enough relationship with a parent to go to them for guidance and the parent could buy it for them but I know that’s asking for too much in our current society. I think for me, I would be comfortable if girls of any age had access to it IF the pharmacist was required to give them a little schpeel first with the whole “This is what to expect for side effects, if x-y-z happens seek medical attention, you could get an earlier period or a heavier period and that’s normal but see a doctor for severe abdominal pain, etc.” If that were the case I would be comfortable with girls of any age buying it because they’re guaranteed to be told what they’re taking and what to expect. The idea of just grabbing it off the shelf and taking it makes me nervous though – just as I wouldn’t want my daughter just to grab birth control pills off the shelf and taking them without having someone in the know give her some guidance on what they are and what side effects are normal and what are not.
The whole “11 year olds could buy it by mistake” thing though is very weird. It does make it sound like the politicians didn’t think it through and are making excuses because they had an ulterior motive for this law.
Barbara and Wayne Snyder says
The argument against Plan B requires very sophisticated and intense thought. The intentional parent has to be prepared to deal with societal, peer, and adolescent pressure. It is not easy! Having said this – We guarantee it is possible to put a love based, value based, spirit influenced life plan in place that will not result in undisciplined behavior, non-chaperoned exposure and children under 16 contemplating adult behavior.
If the solution is to give up the parent role, give society its head and never truly take control of the influences affecting our family and so allow or support artificial prophylactic solutions we give up our freedom as parents and society in general rolls over to the weakest of moral positions. As parents we want what is best for our children and we love them unconditionally; don’t they deserve both from us as parents with the values we ourselves embrace.
Jennifer Wojciechowski says
I believe there is a disconnect between people believing that all parents are educating their children about sex and what reality is.
In an ideal world, all parents are involved in their children’s lives, giving their children self-worth resulting in the confidence it takes to make good decisions.
In the real world, there are 11 year olds who are runaways and throwaways. They get kicked out of the house for hours, days, weeks, or permanently. They get raped and abused repeatedly. Now, let’s deny them the opportunity to prevent a possibly pregnancy because you don’t want your child to have access to FDA approved medicine.
We need to get the politics out of proven healthcare options for the rest of society.
Thank you, Dr Swanson, for speaking up for what’s best for those who can’t speak up for themselves.
I don’t think the answer for the children who don’t have parental support is to just then expect them to be miniature adults with all the responsibility of adults. Saying, “There is no one to parent them so give them adult responsibility” just makes it even harder for them. Instead of giving them unlimited access to adult responsibility, make alternative support from non-parental adults more accessible. What I’m trying to say is the problem is not that a child can’t buy Plan B on their own – the problem is the lack of adult support for some of the girls in our society. If we can conquer that problem it won’t matter that children can’t buy Plan B because all girls will have access to an adult they can go to and say “Look, I made a mistake” or “Look, I just got raped – help me!” and that adult can buy it for them while giving them guidance at the same time. Instead of just throwing them the proverbial bone and letting them grow up alone.
Deb zaret says
Alison, you can believe in your right to have a say in your child’s health care all you like, but the pesky REALITY of the situation is that federal law protects children’s right to confidentiality for all matters related to sex from the age of 13 up. And pediatricians like Seattlemamadoc and I are bound by federal law to provide that confidentiality.
It’s amazing how much controversy the issue of female reproductive health causes. The people who support this decision seem to be living in an ideal world. When you work in the health care field, you have to deal with the real world. People make bad decisions all the time — for example, they overeat and develop heart disease, they smoke and develop lung cancer, they have unprotected sex which results in an unwanted pregnancy. Then there are people who tried to make good decisions but were dealt bad genes or they were responsible with birth control and it failed. Allowing your judgement of a person’s actions or circumstance to justify withholding the treatment that will alleviate their suffering is simply cruel. Insisting young women live according to your ideals causes them to suffer. It does not make the world better or safer or filled with fewer unwanted children.
If the FDA deemed Plan B safe, political motives should not have overruled it. Imagine the outrage if a drug were developed to stop the ability of the HIV virus to infect the human body and it’s access was restricted because of political motive. Only when the drug affects the female reproductive system do we allow political meddling.
I found that Drano statement revolting. I find the idea of a 10 or 11 year old walking into Wallgreens and purchasing this pill about as revolting. In fact, the very idea of a child under the age of consent buying this or having it purchased for them is revolting. I’d like for this medication to remain prescription only for children under age 15. Further I’d like to free Drs of confidentiality and pharmacist requirements so that they may report suspected statutory rape. I think I need some Drano-strength cleanser to get the idea of arming children under the age of consent with contraception and calling it good.
Rape, incest, and injustice against female children aside, I find what Secretary Selebius says:
“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”
Further, the National Abortion Federation reports that women ages 15-19 account for 19% of abortions and have the highest rate of abortion. Why not change the age to requirement to 15?
sigh…. as a prescriber who deals extensively with young women… I can’t tell you how many I see who have developmental delays or psychiatric diagnosis that serve to further impair their ability to make wise choices. In a perfect world no young teen (or younger ) would be put in a position to need plan B. The truth is that they ARE. Being under the age of consent does not stop people from having sex. it just makes it harder for them to do it more safely. I preach abstinence every day…. just ask the parents who come in with their kids. Unfortunately, it’s the kids who don’t have that support who most need a safety net. I support widespread availability of this. I also support every person having timely access to a healthcare professional, it’s just not always possible to see a doctor at a moments notice. Trust me, the health risks of pregnancy FAR outweigh the risk of a dose of plan B.
I understand that, Ann, but who is a young tween having sex with? My middle school in the Bronx served a housing project. The pregnant tweens almost never had same-age partners. Often their baby’s daddy was an older teen or young adult. The developmental delays and psychiatric diagnosis just makes me feel stronger that what’s happening to these young girls is criminal. Organizations like Planned Parenthood may be able to respond in a more timely fashion and provide counseling and intervention where the family pediatrician may not. It’s still really hard for me to stomach a child that age walking out of Wallgreens with this pill and never interacting with an adult other than a cashier.
Jen Brown says
Viki, I completely agree that any older man having sex with a teen below the age of consent, or men who target developmentally disabled or psychiatrically disabled teens, should land in jail and stay there. But I think the situation gets more complex, legally. The age of consent in Washington is 16, and can be lower depending on the age of the sexual partner. Having a developmental delay or psychiatric diagnosis doesn’t make someone who is of the age of consent, less able to give consent, unless their disability is severe. Someone who is delayed enough, or disabled enough, to be legally deemed unable to give consent is also going to be unable to walk into a pharmacy and complete a purchase.
Men who target younger teens (below 16) as sexual partners are certainly doing something illegal, but actually having them prosecuted can be difficult (although certainly not impossible.) The teen needs to voluntarily disclose the age of her partner, which is very rare when they feel the relationship is consensual. “How old is your boyfriend?” is not something that clinicians are required to ask or verify. Most teen girls in relationships with older men feel that they are “mature for their age” and don’t see any problem with it.
It would be wonderful if teens felt safe going to get reproductive care, knew where to go, and were able to advocate for themselves. Unfortunately, that’s often not the case. If a teen is not going to seek care after what may result in a pregnancy, I’d rather they be able to access Plan B and prevent that pregnancy- even if they aren’t able to speak with an adult- as opposed to becoming pregnant and having their future drastically altered. I feel that if a teen is already tied into the health care system, they will see their provider about this- although the 3-day deadline can be a barrier. If not, let’s at least make sure they don’t have an unwanted pregnancy on their hands that can have so many adverse emotional, physical, and economic effects.